NCT02351960

Dexlansoprazole in Asian Participants With Gastroesophageal Reflux Disease

A Phase 4, Open-Label Study in Patients From Asia With Gastroesophageal Reflux Disease Treated With Dexlansoprazole

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 296 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effectiveness of symptom control in gastroesophageal reflux disease (GERD) participants following treatment with dexlansoprazole.

Detailed description

The drug being tested in this study is called dexlansoprazole. A dual delayed release formulation of dexlansoprazole, referred to as dexlansoprazole modified release (dexlansoprazole MR) was tested to treat people who have gastroesophageal reflux disease (GERD). This study looked at the healing of the esophageal lining of the GERD participants who took dexlansoprazole MR. The study enrolled 296 patients. Participants were assigned to two study groups based on the endoscopy screening procedures to receive treatments as follows: * Dexlansoprazole 30 mg to participants with non-erosive reflux disease (NERD) * Dexlansoprazole 60 mg to participants with erosive esophagitis (EE) All participants were asked to take one capsule in the morning each day throughout the study. All participants were asked to record the presence and maximum severity of daytime and nighttime heartburn and regurgitation symptoms during screening and, if assigned to a treatment group, throughout the duration of the study using the supplied paper diary. This multi-center trial was conducted in Asia (Hong Kong, Taiwan, South Korea). The overall time to participate in this study was up to 8 weeks. Participants would make up to 3 visits to the clinic, and would be contacted by telephone 30 days after the last dose of study drug for a follow-up assessment.

Conditions

• Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
DRUG	Dexlansoprazole	Dexlansoprazole capsules

Timeline

• Start date: 2015-03-19
• Primary completion: 2016-06-22
• Completion: 2016-07-13
• First posted: 2015-01-30
• Last updated: 2017-10-04
• Results posted: 2017-10-04

Locations

10 sites across 3 countries: Hong Kong, South Korea, Taiwan